番茄社区app

The FDA issued an emergency use authorization (EUA) for bebtelovimab, a monoclonal antibody that "retains activity against Omicron," the

Bebtelovimab is authorized for the treatment of mild to moderate COVID-19 in individuals ages 12 and up who are at risk of progressing to severe disease.

Importantly, "laboratory testing showed that bebtelovimab retains activity against both the Omicron variant and the BA.2 Omicron subvariant," the agency added, without providing any more specifics.

The antibody is not authorized for hospitalized patients or those requiring oxygen therapy, as it has not been studied in this population and could worsen clinical outcomes, FDA said.

"Today's action makes available another monoclonal antibody that shows activity against Omicron, at a time when we are seeking to further increase supply," said Patrizia Cavazzoni, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement.

Data supporting this EUA came from the phase II , which in part enrolled 150 high-risk patients who were randomized to receive either bebtelovimab alone or in combination with other monoclonal antibodies. An additional 176 patients received the drug with other monoclonal antibodies in an open-label arm of the trial.

FDA said that COVID-related hospitalizations and deaths were lower among patients who received bebtelovimab alone or in combination with other antibodies versus those who received placebo, but "conclusions are limited as these data are from different trials that were conducted when different viral variants were circulating and baseline risk factors varied."

Clinically, bebtelovimab produced similar results as monotherapy or in combination with other antibodies, the agency added.

Adverse events included itching, rash, infusion-related reactions, nausea, and vomiting. Serious adverse events such as hypersensitivity, anaphylaxis, and infusion-related reactions were reported with other monoclonal antibodies, and the FDA warned that they could occur with bebtelovimab. Clinical worsening is also a possibility, though the agency noted that it is unclear whether this would be due to the treatment or progression of COVID itself.

Manufacturer Eli Lilly said that they have an agreement with the U.S. government to supply 600,000 doses of the drug by March 31, with the option of 500,000 additional doses by the end of July.

Comment